(233 days)
The High Tibial Osteotomy System is indicated for fixation of high tibial osteotomy.
The High Tibial Osteotomy System consists of a pre-contoured plate and self-tapping screws in various sizes for high tibial osteotomy. The plates and screws are manufactured from titanium alloy and color anodized. The High Tibial Osteotomy System will be provided sterile.
This document is a 510(k) premarket notification for a medical device (High Tibial Osteotomy System), not a study report for an AI/ML powered device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML application.
Specifically, the document states:
- "No clinical studies were performed." (Page 4, Section 8, "Clinical Test Summary:")
- It refers to "Non-clinical Test Summary" which lists "Comparative fatigue compression tests," "Comparative static compression tests," "Geometric analysis of the subject and predicate screws," and "Torsional engineering analysis of plates." These are engineering and material tests, not performance studies for an AI/ML algorithm.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2015
NEWCLIP TECHNICS % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K141548
Trade/Device Name: High Tibial Osteotomy System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 24, 2014 Received: December 29, 2014
Dear Mr. Webb:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems
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Page 2 - Mr. J.D. Webb
(OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
High Tibial Osteotomy System
Indications for Use (Describe)
The High Tibial Osteotomy System is indicated for fixation of high tibial osteotomy.
Type of Use (Select one or both, as applicable)
X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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510 (k) Summary for the High Tibial Osteotomy System 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the High Tibial Osteotomy System.
Summary preparation date: January 26, 2015
| 1. Submitter: | Contact Person: |
|---|---|
| NEWCLIP TECHNICSP.A. de la Lande Saint Martin45 rue des GarottièresF-44115 Haute-Goulaine - FranceTelephone: (33) 2 28 21 37 12 | J.D. WebbThe OrthoMedix Group, Inc.1001 Oakwood BlvdRound Rock, TX 78681Telephone: 512-388-0199 |
| 2. Trade name: | High Tibial Osteotomy System |
| Common Name: | Plates for high tibial osteotomyScrews for high tibial osteotomy |
| Class: | II |
| Product code: | HRS/HWC |
| Classification Name: | Plate, Fixation, Bone(21 CFR part. 888.3030)Screw, Fixation, Bone(21 CFR part. 888.3040) |
3. Predicate or legally marketed devices which are substantially equivalent:
- The Arthrex Titanium Opening Wedge Osteotomy System of Arthrex, Inc. • (K032187),
- The Surfix® Knee Osteotomy System of Surfix Technologies S.A. • (K041601),
- The Humerus Locking Plating System of Newclip Technics (K063095). .
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| 4. Description of the device: | The High Tibial Osteotomy Systemconsists of a pre-contoured plate and self-tapping screws in various sizes for hightibial osteotomy. The plates and screws aremanufactured from titanium alloy andcolor anodized. The High TibialOsteotomy System will be providedsterile. |
|---|---|
| Materials: | Titanium alloy Ti-6Al-4V ELI (conform toASTM F 136-12a and/or ISO 5832-3). |
| Function: | The implants of the High TibialOsteotomy System are indicated forfixation of high tibial osteotomy. |
5. Substantial equivalence claimed to predicate devices:
The High Tibial Osteotomy System is substantially equivalent to the Arthrex Titanium Opening Wedge Osteotomy System of Arthrex, Inc. (K032187), to the Surfix Knee Osteotomy System of Surfix Technologies S.A. (K041601) and to the Humerus Locking Plating System of Newclip Technics (K063095) in terms of intended use, design, materials used, mechanical safety and performance.
6. Intended use:
The High Tibial Osteotomy System is indicated for fixation of high tibial osteotomy.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative fatigue compression tests. .
- Comparative static compression tests. ●
- Geometric analysis of the subject and predicate screws. .
- Torsional engineering analysis of plates. .
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
The High Tibial Osteotomy System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.